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ONGLYZA (SAXAGLIPTIN): PRESCRIBING INFORMATION
Saxagliptin is an orally-active inhibitor of the DPP4 enzyme.
Saxagliptin Monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3hydroxytricyclo[220.127.116.11,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile,
monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2.H2O and
the molecular weight is 333.43.
Saxagliptin Monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in ethanol, methanol, isopropyl alcohol, acetone, acetonitrile, and polyethylene glycol 400 (PEG 400).
Each film-coated tablet of Onglyza for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, and iron oxides.
INDICATIONS AND USAGE
Monotherapy and Combination Therapy
Onglyza (Saxagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
Important Limitations of Use
Onglyza (Saxagliptin HCl) should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
DOSAGE AND ADMINISTRATION
Onglyza dosage and administration
DOSAGE FORMS AND STRENGTHS
Onglyza (Saxagliptin Hydrochloride) 5 mg tablets are pink, biconvex, round, film-coated tablets with "5" printed on one side and "4215" printed on the reverse side, in blue ink.
Saxagliptin (Onglyza) 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets with "2.5" printed on one side and "4214" printed on the reverse side, in blue ink.
WARNINGS AND PRECAUTIONS
Use with Medications Known to Cause Hypoglycemia
Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with Saxagliptin HCl (Onglyza).
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Saxagliptin Hydrochloride (Onglyza) or any other antidiabetic drug.
Onglyza adverse reactions
Strong Inhibitors of CYP3A4/5 Enzymes
Ketoconazole significantly increased saxagliptin exposure. Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., clarithromycin, atazanavir, indinavir, nefazodone, itraconazole, nelfinavir, saquinavir, ritonavir, and telithromycin). The dose of Saxagliptin Hydrochloride (Onglyza) should be limited to 2.5 mg when coadministered with a strong CYP3A4/5 inhibitor.
USE IN SPECIFIC POPULATIONS
Onglyza use in specific populations
In a controlled clinical trial, once-daily, orally-administered Saxagliptin Hydrochloride (Onglyza) in healthy subjects at doses up to 400 mg daily for 2 weeks (80 times the MRHD) had no dose-related clinical adverse reactions and no clinically meaningful effect on QTc interval or heart rate.
In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status. Saxagliptin and its active metabolite are removed by hemodialysis (23% of dose over 4 hours).
Onglyza clinical pharmacology
Onglyza nonclinical toxicology
Onglyza clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Onglyza (Saxagliptin) tablets have markings on both sides and are available in the strengths and packages:
Onglyza 5 mg
Film-Coated Tablet Color / Shape: pink biconvex, round
Tablet Markings: "5" on one side and "4215" on the reverse, in blue ink
Package Size: Bottles of 30, 90, 100, 500
Onglyza 2.5 mg mg
Film-Coated Tablet Color / Shape: pale yellow to light yellow biconvex, round
Tablet Markings: "2.5" on one side and "4214" on the reverse, in blue ink
Package Size: Bottles of 30, 90
Storage and Handling
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Manufactured and distributed by Bristol-Myers Squibb, AstraZeneca pharmaceutical companies and its divisions.
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